CompletedPhase 4ACTRN12611001018909

Tramadol administration in the critically ill

Pharmacokinetics of Subcutaneous Tramadol in Intensive Care Unit (ICU) step down patients

Sponsor

Guy Ludbrook

Enrollment

15 participants

Start Date

Apr 24, 2010

Study Type

Interventional

Conditions

Intensive Care Unit (ICU) Step Down patients who require patient controlled analgesia (PCA) Fentanyl as part of their management after trauma or surgery.

Summary

The study enabled dosing intervals, peak plasma concentration and rate of absorption of subcutaneous tramadol to be determined in Intensive Care Step Down Unit patients. It also permitted pharmacokinetic comparison with other subcutaneous opioids and assist in clinical decision-making about optimal opioid dosing regimens for moderate to severe acute pain.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria2

ICU Step down patients who require patient controlled analgesia(PCA) Fentanyl as part of their management after trauma or surgery
Adequate venous access to collect blood

Exclusion Criteria6

Contraindication and/or allergy to the use of Tramadol or Fentanyl
Significant hepatic impairment (3 times the limit of upper range Liver Function Test)
Chronic use of central nervous system depressants
Drugs that inhibit CYP2D6 activity
History of epilepsy
Renal dysfunction (creatinine clearance of less than or equal to 75ml/min)

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Interventions

Tramadol Hydrochloride 50mg one injection only on study day. Administered over 1 minute subcutaneously

Locations(1)

Australia

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ACTRN12611001018909